Phytopharmacovigilance

A scheme for monitoring the adverse effects of plant protection products

Plant protection products can present risks to human health, ecosystems and living organisms that need to be identified in order to be monitored. In this context, along with the management of marketing authorisations for plant protection products, the Act of 13 October 2014 on the future of agriculture, food and forests has entrusted ANSES with establishing a phytopharmacovigilance scheme. Its objective is to monitor the adverse effects of plant protection products available on the market, covering the contamination of environments, exposure and its impacts on living organisms and ecosystems, and phenomena of emergence of resistance.

Definition

In the framework of the Act of 13 October 2014 on the future of agriculture, food and forests, ANSES has been entrusted with setting up a phytopharmacovigilance scheme. This vigilance scheme covers the contamination of environments, exposure and its impacts on living organisms, including human health and ecosystems as a whole, and phenomena of emergence of resistance.

Phytopharmacovigilance is the latest complement to ANSES's existing missions of a priori assessment of the risks associated with plant protection products, and issuing and withdrawal of marketing authorisations. It is also fully in line with the third component of the Ecophyto plan[1].

Monitor the adverse effects of plant protection products on the market

The objective of phytopharmacovigilance is to detect as early as possible any signals that may require measures to be taken to prevent or limit the risks associated with plant protection products. This scheme gives the Agency the means to anticipate, detect, analyse and prevent the adverse effects of plant protection products.

Three pillars

To meet this objective, phytopharmacovigilance relies on three fundamental and complementary methods of data collection and knowledge production: a network of surveillance or vigilance bodies, ad hoc studies, and collection of spontaneous reports.

Surveillance or vigilance organisations

Phytopharmacovigilance is based on the systematic and regular collection of information produced by the existing surveillance and vigilance bodies, in the areas it covers: the adverse effects of plant protection products on humans, farmed animals and wildlife (including honeybees), on ecosystems as a whole (biodiversity, crops, fauna, flora, air, water, soil) and on food, as well as the emergence of phenomena of resistance to plant protection products.

This scheme therefore includes the French Ministries' surveillance plans on water and food, and the compilation of unintended effects in the framework of regional biological monitoring (SBT). The other participants in this network are:

Ad hoc studies

Ad hoc studies are carried out on the adverse effects of plant protection products when the information provided by the surveillance and vigilance bodies is seen to warrant clarification. The first studies implemented should lead to improved knowledge of cropping practices and the reliance on plant protection products (INRA), the acquisition of data on concentrations in humans in the framework of the national biomonitoring programme (SPF), and exploitation of information derived from the CAP-TVs. A specific scheme for funding these studies is planned through a tax on sales of plant protection products payable by the marketing authorisation holders.

Reports by stakeholders

Lastly, ANSES also receives reports from professionals such as the marketing authorisation holders, manufacturers, importers, distributors or professional users of plant protection products, in addition to the advisers and trainers of these users. These reports are essential for phytopharmacovigilance, since these stakeholders are directly in contact with the professionals in the field.

What is the ultimate purpose?

Pooling the information derived from the surveillance or vigilance schemes, conducting ad hoc studies and collecting spontaneous reports makes it possible to meet the three objectives set by the phytopharmacovigilance scheme:

enable the marketing authorisation conditions of products marketed today to be adapted, if necessary (for example by reducing doses, adapting the conditions of application or withdrawing a marketing authorisation);

define cross-cutting management measures, for example for protecting people in the vicinity of the treated areas;

contribute to enforcing compliance with the prohibitions of uses of products, especially those whose active substances are no longer approved at European level.

[1] To assess, control and reduce the risks and impacts of plant protection products on human health and the environment